From bedwetting to chronic constipation, pelvic health conditions can take a significant toll on children’s physical, emotional, and social well-being. Missed school days, embarrassment from daytime incontinence and anxiety about symptoms can interfere with learning and friendships. Children may avoid important childhood milestones, such as slumber parties and social activities, or spend valuable time in medical appointments instead of simply being kids. These experiences can affect confidence, limit social development, and contribute to ongoing emotional distress and mental health challenges.
Seeing these kids struggle with their health and the existing treatment options – including devices restricted to provider’s offices and not designed with children in mind – gave Juliette Hawa, PT, DPT, a staff pediatric pelvic health physical therapist at Children’s Hospital Colorado, an idea:
Why not create a therapy device that meets kids where many are comfortable: playing video games at home?
Hawa developed PFRx, a gamified biofeedback device specifically designed for children.
“PFRx was created to help children regain confidence by being in control of their bodily functions, improve their quality of life, and get back to simply being kids,” said Hawa.
Hawa’s work started after seeing patients come through Children’s Hospital Colorado’s Neurogastroenterology and Motility Program – one of only a dozen such programs nationally. Hearing hundreds of stories of her patients and their families sparked her entrepreneurial journey, in concert with CU Anschutz Innovations, to develop PFRx and bring her idea into clinical studies and, eventually, to patients.
What can pelvic floor dysfunction cause?
When the pelvic muscles are out of sync, either too relaxed or too tight, they can lead to a wide variety of gastrointestinal (GI) and urological health symptoms. These range from:
Upper Gastrointestinal (GI) Tract
Reflux
Stomach pain
Nausea
Lower GI Tract
Constipation
Inflammatory bowel symptoms
Encopresis (uncontrolled passing of stool)
Urology
Dysfunctional voiding or urine incontinence, including bedwetting
Urinary tract infections
“We see many children come into appointments feeling anxious about what to expect,” Hawa said. “Often, that anxiety is tied to feeling a lack of control over their own bodies. Children have limited control over many aspects of their lives, but they can learn to understand and influence how their bodies respond. Because you can’t strengthen the pelvic floor the same way you lift weights, biofeedback helps children learn to recruit and coordinate their pelvic floor muscles more effectively, with the goal of reducing or eliminating their symptoms and giving them a greater sense of confidence and control.”
Pelvic health issues can begin with the diaphragm.
“The abdominal cavity functions as a pressure system, with the diaphragm moving pressure up and down with every breath, roughly 25,000 times a day,” said Hawa.
Hawa explains that If rib mobility is restricted, postural muscles are tight, or breathing patterns are altered, the diaphragm may not move as efficiently or coordinate normally with the abdominal and pelvic floor muscles.
“Because these systems work together, changes in breathing and pressure management can affect how the pelvic floor functions,” she adds.
Hawa says to imagine a hammock. If you put one person in a hammock, it stays taut and fine. With three people, however, the extra pressure causes the hammock to sag.
Similarly, when something is out of sync in the body, pelvic health issues can arise. These can range from a variety of musculoskeletal issues, muscle imbalances in the abdominal/pelvic system and postural system, flat feet, toe walking, gait deviations or leg length discrepancy, Hawa said. A biofeedback device can help with pelvic muscle identification as a physical therapist works to untangle the cause and corrective therapy once the muscles are pinpointed.
Biofeedback technology for pediatric physical therapy lags, Hawa said. “There are two primary models most physical therapists use,” she said. “One is currently being phased out and discontinued, while the second is not designed with only kids in mind – making it less fun and less likely that patients will be fully engaged in any exercises.”
With PFRx, kids often reported a better response and met their medical goals faster, learning and practicing their muscle coordination exercises in a fun and engaging way, Hawa said.
That fun and engagement comes from a video game approach.
“Think of your muscles as the controller for the video game,” Hawa said. “PFRx device and its external electrodes connect to a smartphone or tablet via Bluetooth and the character responds on screen during muscle contractions or relaxation.”
One such game is to help a mother bird find and rescue her lost baby birds and return them home. And with different levels and incentives, such as improving wardrobes for their characters, kids learn to identify and improve muscle function in their pelvic floor with fun incentives. The goal is better body awareness, with less pain, packaged in a tool that a child can use in the comfort of home with periodic provider check-ins.
Because the Neurogastroenterology and Motility Program at Children’s Hospital Colorado is one of only a dozen offered nationally, patient families often live long distances in rural areas or surrounding states. PFRx can help these children get their therapy with home based options, Hawa said.
“Imagine a child struggling with constipation,” Hawa said. “They may have been dealing with symptoms for months before they can even get an appointment. During that time, abnormal muscle coordination, difficulty relaxing the pelvic floor, and learned toileting habits can become increasingly ingrained, creating a cycle that becomes harder to break. The longer these patterns persist, the more challenging it can be to restore healthy bowel function and muscle control.”
To improve access, PFRx is designed to be used by medical assistants, nurses, physician assistants, pediatricians, mental health providers, and others outside the physical therapy space.
“We don’t want kids languishing in discomfort and pain before getting in to see a physical therapist,” Hawa said.
Hawa said PFRx is designed to give children the opportunity to begin a clinician guided treatment program at home while they wait for an appointment.
“By the time they come into the clinic, they can already have experience using biofeedback and practicing their pelvic floor exercises, giving us a head start on treatment,” she said.
PFRx’s vision is to continually enhance the device through software updates, new gamified experiences, and personalized treatment plans. As the digital platform evolves, healthcare providers will also be able to remotely update treatment programs, adjust therapy based on a child’s progress, and monitor performance, creating a more connected and responsive model of pediatric pelvic health care.
Bringing medical inventions such as Hawa’s to clinics is a long process. Yet Hawa has a partnership behind the scenes that has been helping to accelerate her work.
CU Anschutz Innovations, a campus resource for biomedical technology commercialization, began working alongside Hawa after she was one of four winners in a 2019 innovations challenge, resulting in an early funding prize and request for a prototype.
“There is a strong interest in advancing innovations in pediatric care because interventions during childhood can have a profound impact on a child’s development and long-term health outcomes throughout their life,” said Gali Baler, PhD, the managing director of ventures and investments at CU Anschutz Innovations.
Since 2019, Baler’s team has answered many questions and helped guide Hawa on everything from micro-grant funding, business development and market analysis, venture capital funding connections and more.
In his 10 years with the university, Baler said, a differentiating factor in bringing concepts like Hawa’s to patients and the broader healthcare market is the individual passion a provider or researcher has for their work.
“I’ve seen how Juliette interacts with her patients in the clinic,” Baler said. “I was struck by her level of care, attention to detail and passion to make her patients feel better.”
Hawa is grateful for the team’s help. “I feel like they believed in me when I didn't even know whether this was possible,” she said. “Each step of the way, they’ve been there to help. I know how to run a physical therapy business, but I knew nothing about launching a startup.”
PFRx is currently in talks with the FDA and submitting a 510(K) to the U.S. Food and Drug Administration, the regulatory pathway many medical devices use to obtain clearance before they can be marketed to healthcare providers and patients.
Meanwhile, Hawa stays grounded by focusing on her patients.
“We had one child who had been feeling sick for more than a year. He wasn’t going to school, wasn’t eating, and generally felt miserable,” Hawa recalled. “Once we helped him improve his muscle coordination and established a treatment plan, his quality of life began to change. He has since gained 20 pounds and is now talking about wanting to play in the World Cup after watching it this summer. Seeing a child go from feeling so unwell to dreaming big again is what makes this work so rewarding.”
Key points:
- Pelvic floor dysfunction affects millions of children, with a myriad of resulting health and social challenges.
- A researcher named Juliette Hawa at Children’s Hospital Colorado is looking to help these young patients by making their therapy more accessible with her video game inspired biofeedback device PFRx.
- Thanks to a partnership with CU Anschutz Innovations and Children’s Hospital Colorado, Hawa is hoping to bring her idea to life.